Role of Body Composition in Large for Gestational Age Infants (LGA) With Oral Feeding Difficulty

Pilot Randomized Controlled Trial Comparing FFM-indexed Feeding vs. Standard Feeding in LGA Infants With Oral Feeding Difficulty and Disproportionate Body Composition.

Large for Gestational Age (LGA) infants have excess fat-mass (FM) proportion secondary to prolonged in utero exposure to an energy-rich environment. Our preliminary data suggest that excess FM proportion can be associated with oral feeding delay and a potentially modifiable therapeutic target to improve oral feeding outcomes. The objective of this study is to determine the impact of a short-term Fat-free mass (FFM)-indexed feeding on the oral intake volumes in LGA infants with oral feeding difficulties.

Study Overview

• Status: Not yet recruiting
• Conditions: Body Composition; Feeding; Difficult, Newborn; Nutrition Disorder, Infant
• Intervention / Treatment: Other: Dietary intervention

Detailed Description

Eligible subjects will be randomized to an innovative FFM-indexed feeding or the standard feeding for up to 2 weeks. The essential component of the FFM-indexed feeding will be the difference in milk prescription dosing that we propose to set the feeding volume to index FFM rather than total mass. In FFM-indexed feeding, there will be a permissive feeding volume restriction to 150 ± 10 mL/kg (FFM)/day without increasing the milk calorie density or changing the type of formula milk, whereas the standard feeding will include a feeding volume goal of 150 ± 10 mL/kg (body weight)/day. Infants will receive either breast milk or formula feedings per the standard feeding protocols. Body composition (PEAPOD system) and appetite-regulating hormones (ARH) levels of enrolled infants will be assessed at baseline (test-1) and at the end 2-week study intervention period (test-2). Subjects will be followed for clinical and growth outcomes until neonatal intensive care unit (NICU) discharge and through 6 months of age. Growth will be followed through 6 months of age by retrieving anthropometric measurement records from pediatricians at well-child visits (2-, 4-, 6- and 6-month visits). Parents will be called at these time points to obtain a history of any further feeding difficulties.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sreekanth K Viswanathan, MD,MS; Phone Number: 4076977603; Email: sreekanth.viswanathan@nemours.org

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32827
      • Nemours Children's Hospital
      • Contact: Sreekanth K Viswanathan; Phone Number: 407-697-7603; Email: sreekanth.viswanathan@nemours.org
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
      • Contact: Kera McNelis, MD; Email: kera.mcnelis@cchmc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 2 months (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• LGA infants with oral feeding difficulty born at ≥ 35 weeks gestation, with FM z-score > +1.0 in body composition measurement

Exclusion Criteria:

• Infants on any respiratory support, Infants on enteral feeding duration > 60 minutes due to hypoglycemia concerns, videofluoroscopic swallow study (VFSS) demonstrating unsafe swallowing function, GI surgical conditions, significant neurological morbidities, and major congenital, genetic syndromes/anomalies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: FFM-indexed feeding; In FFM-indexed feeding, there will be a permissive feeding volume restriction to 150 ± 10 mL/kg (FFM)/day without increasing the milk calorie density or changing the type of formula milk for 2 weeks in the intervention group	Other: Dietary intervention; energy-restricted diet appropriate for resting metabolic rate using FFM as proxy
Active Comparator: Standard feeding; The standard feeding approach will include an oral feeding volume goal of 150 ± 10 mL/kg/day during the 2-week study period	Other: Dietary intervention; energy-restricted diet appropriate for resting metabolic rate using FFM as proxy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from study entry to independent oral feeding	full oral feeding defined as 120 ml/kg/d without tube feeding for 2 consecutive days	Before or at NICU-discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oral feeding volume at NICU discharge	oral feeding volume (mL/kg/day) at discharge	before 3 months
NICU Feeding related length of stay (LOS)	Days from first oral feeding to independent oral feeding	before 3 months
Gastrostomy rates	Percentage of infants with gastrostomy placement	through study completion, an average of 1 year
ARH levels	Directional changes in ARH pre-post intervention	2 weeks
Oral feeding success rate	Independent oral feeding at NICU discharge	Before 3 months
Body composition change in FM and FFM	Directional changes in FM and FFM pre-post intervention	2 weeks

Collaborators and Investigators

• Sponsor: Nemours Children's Clinic
• Collaborators: Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Infant Nutrition Disorders
• Other Study ID Numbers: 871760

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Once study started enrolling
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No